Ex Parte Moya Argilagos et al

Patent Trial and Appeal Board

Mar 29, 2018

12989578 (P.T.A.B. Mar. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/989,578 08/06/2012
23909 7590 04/02/2018
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Dally Moya Argilagos
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
8618-00-US-Ol-GB 1027
EXAMINER
ROBERTS, LEZAH
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
04/02/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
Patent_Mail@colpal.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DALLY MOY A ARGILAGOS,
TURAN MATUR, and CORNELIA SCHEFFEL
Appeal2017-007016
Application 12/989,578 1
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, AND
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1, 2, 4--8,
10-12, 19-25, 27, and 28 (App. Br. 4). 2 Examiner entered a rejection under
35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as "Colgate-Palmolive
Company" (App. Br. 2).
2 Pending "[ c ]laims 9, 14, 15, and 26 [stand] withdrawn" from consideration
(App. Br. 4).
Appeal2017-007016
Application 12/989,578
STATEMENT OF THE CASE
Appellants' disclosure "relates to the field of oral care compositions,
in particular mouthrinses, and their use in treating or preventing erosive
tooth demineralization in acidic media, brought about by food acids or
endogenous acids such as gastric juice" (Spec. 2). Claim 1 is representative
and reproduced below.
1. An oral care composition comprising a liquid phase
containing 30% to 90% by weight, based on the liquid phase, of
water;
dissolved tin from stannous chloride;
200 to 2000 ppm fluoride ions, based on the oral
composition; and
5 to 60% by weight, based on the oral care composition,
of a Cc3-5) sugar alcohol;
wherein the content of dissolved tin [Sn] in the liquid phase is
at least 7 50 ppm, based on the composition;
wherein 60 mol % or more of the content of dissolved tin [Sn]
is in the formal oxidation state +II;
wherein the composition comprises 0.01 to 10 % by weight of
an organic acid, based on the composition and ammonium
cations of the formula (I):
R-NH+ Ra-[(CH2)u-NH+Rb]v-Rc (I)
wherein Risa saturated or unsaturated straight-chain
hydrocarbon residue of 10 to 20 carbon atoms, v is an integer
from 0 to 1, u is an integer from 2 to 3 and Ra, Rb and Re are
independently selected from hydrogen and -CH2CH20H;
wherein the ammonium cations of formula (I) are present as
their hydrofluoride salts; and
wherein the composition is in the form of a mouthrinse.
(App. Br. 10.)
2
Appeal2017-007016
Application 12/989,578
The claims stand rejected as follows:
Claims 1, 2, 4--8, 10-12, 19--25, 27, and 28 stand rejected under
35 U.S.C. § 103(a) as unpatentable over the combination ofMuhlemann3
and Fiscella. 4
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Muhlemann
relates to a process for stabilizing oral compositions[, such as
mouthwashes, mouth sprays, rinsing tablets, ... solutions for
local application and the like,] for the prophylaxis and
combating of plaque formation and of dental caries, which
compositions contain one or more tin (II) salts in a water
containing medium, and whose stability over a lengthy period is
ensured through stabilisation of the tin salt( s ).
(Muhlemann 1: 5-10; see id. at 11. 11-14; see generally Ans. 2.)
FF 2. Muhlemann discloses
that the addition of certain water-soluble organic diamine salts
to aqueous media which contain tin(II) fluoride, other tin(II)
salts or mixtures of fluorine-free tin salts with fluorides of other
metals, usually, at a tin concentration of 0.005 to 0.5% by
weight, permits the preparation of stable, precipitate-free
formulations for the care of the mouth and of the teeth.
(Muhlemann 2: 43-50; see generally Ans. 2-3.)
3 Miihlemann et al., US 4,828,822, issued May 9, 1989.
4 Fiscella et al., US 3,282,792, issued Nov. 1, 1966.
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Application 12/989,578
FF 3. Muhlemann discloses:
When tin(II) fluoride is used, the concentration should
advantageously be within the range of 0.04 to 0.6% by weight
of SnF2. Solutions of tin(II) fluoride are stabilized by the
addition of one or more water-soluble organic amine salts in a
weight ration of Sn : amine which is suitable from 1: 10 to 10: 1.
Preferably, the two components are employed in equimolar
concentration.
(Muhlemann 2: 51-58; see Ans. 3.)
FF 4. Muhlemann discloses:
Tin salts which can be employed are, in particular, tin(II)
fluoride, chloride, bromide, sulfate or tartrate. Accordingly,
tin(II) fluoride in particular, preferably in a concentration of
0.05 to 0.5% by weight of Sn, will tend to be used, or the tin
ions will be added in the form of a fluorine-free tin salt, such as
the other tin salts mentioned above, but in that case
advantageously in conjunction with sodium fluoride, potassium
fluoride, ammonium fluoride or fluorides of other metals.
(Muhlemann 3: 1-9; see Ans. 2.)
FF 5. Muhlemann discloses the incorporation of a sufficient amount of
least one diamine salt, which is a cationic surfactant, to compositions
comprising at least one tin(II) salt to stabilize the tin salt(s) (Muhlemann 2:
62----67; see generally Ans. 3).
FF 6. Muhlemann discloses:
Amongst the [ diamine salt] compounds which have
proved very particularly suitable are aliphatic tertiary diamines
which have one alkyl group derived from a fatty acid and two
polyoxyethylene groups bonded to the nitrogen atom and
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Application 12/989,578
containing a total of 20 to 50 ethyleneoxy groups, in particular
compounds of the formula:
wherein R[2J denotes a fatty alkyl group with 7 to 19 carbon
atoms and x, y and z each denote an integer from 1 onwards,
preferably from 1 to 10. These compounds are used in the form
of their salts with inorganic or organic acids. A typical
example of such a compound is N,N,N' -tris-(2-hydroxyethyl)-
N' -octadecyl-1,3-diaminopropane, which, in the form of the
dihydrofluoride, is referred to as amine fluoride 297 and
abbreviated to AmF 297.
(Muhlemann 3: 14--34; see Ans. 2.)
FF 7. Muhlemann discloses:
Suitable acid components of the amine salt are all acids
which impart solubility in water to the particular amine and
which, neither therapeutically nor for any other reason, are
objectionable for use in the mouth. Suitable acids of this type
are in particular hydrofluoric acid, hydrochloric acid,
phosphoric acid, gluconic acid or adipic acid. A particularly
preferred amine salt is the dihydrofluoride of the above-
mentioned 1,3-diaminopropane.
(Muhlemann 4: 1-9; see Ans. 3.)
FF 8. Muhlemann exemplifies a mouthwash composition comprising 0.2%
N,N,N'-tris-(2-Hydroxyethyl)-N'---octadecyl-1,3-diaminopropane
dihydrofluoride, 0.1 % Tin(II) fluoride, 10.0% Glycerol (i.e. a C3_5 sugar
alcohol), 0.145% Flavourings, and 89.555% water (Muhlemann 9: 30-40;
see Ans. 3).
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Application 12/989,578
FF 9. Examiner finds that Muhlemann "differ[s] from ... [Appellants']
claims insofar as it does not disclose a carboxylic acid in the composition
other than the amine salt" (Ans. 3).
FF 10. Fiscella "relates to aqueous compositions including mouth washes
and dentifrices containing stannous fluoride, with said stannous fluoride
being maintained in soluble and stable form" (Fiscella 1: 13-16; Ans. 3).
FF 11. Fiscella discloses:
It has been found that the presence of the hydroxyl
substituted aliphatic di- and tri-carboxylic acids, or a water-
soluble salt thereof, is effective to prevent the precipitation of
the stannous ion and consequent loss of fluoride ion from
solution and to stabilize the tin in the stannous, or other than
stannic, form while it is in the solution.
(Fiscella 1: 63---68; Ans. 3.)
FF 12. Fiscella discloses:
The concentrations of the di- and tri-carboxylic acids of
[Fiscella' s disclosure] and salts thereof are desirably between
about 0.05% to 10% by weight of the composition. There is no
criticality of concentrations in this range. For dentifrices, the
concentration is preferably from about 0.1 % to 5%, with 1 to
5% more desirable and with 2% most desirable. For mouth
washes, 0.05 to 3 % is desirable with 0.5% preferred. For
dental topical solutions 5 to 10% is preferred.
(Fiscella 2: 51---60; Ans. 3.)
ANALYSIS
Examiner finds that Muhlemann discloses the composition set forth in
Appellants' claim 1, but for an organic acid, i.e. "a carboxylic acid ... other
than [an] amine salt" (see FF 1-9; Ans. 2-3). To make up for this deficiency
in Muhlemann, Examiner finds that Fiscella discloses mouthwash
compositions comprising stannous fluoride and a "hydroxyl substituted
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aliphatic di- and tri-carboxylic acid [] effective to prevent the precipitation
of the stannous ion and consequent loss of fluoride ion from solution and to
stabilize the tin in the stannous, or other [] stannic form, while it is in
solution" (see FF 10-12; Ans. 3). As Examiner explains,
Fiscella teaches specifically that the presence of [] hydroxyl
substituted aliphatic di- and tri-carboxylic acid is effective to
prevent the precipitation of the stannous ion and consequent
loss of fluoride ion from solution and to stabilize the tin in the
stannous ... while it is in solution . . . . This is strong
motivation to add an acid to compositions comprising stannous
salts. Therefore one of ordinary skill in the art would [have]
be[ en] motivated to use an acid in the compositions of
Muhlemann to stabilize the compositions. One would also
reasonably conclude that this would stabilize the fluoride and
make it more efficient in performing its therapeutic function.
(Ans. 6 (citing Fiscella 1: 6-72); see also FF 1-12.) Thus, based on the
combination of Muhlemann and Fiscella, Examiner concludes that, at the
time Appellants' invention was made, it would have been prima facie
obvious "to have added a hydroxyl substituted aliphatic di- and tri-
carboxylic acid to the mouth washes of Muhlemann ... motivated by the
desire to add stability to the stannous compound as disclosed by Fiscella"
(Ans. 3--4 and 6).
We find no error in Examiner's conclusion of obviousness (see id.; FF
1-12). KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) ("The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results"). See also id.,
550 U.S. at 417 ("if a technique has been used to improve one device, and a
person of ordinary skill in the art would recognize that it would improve
similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill").
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Application 12/989,578
For the foregoing reasons, we are not persuaded by Appellants'
contention that "neither Muhlemann nor Fiscella would have been a logical
lead reference, and the Examiner has not presented a legally sufficient
suggestion or motivation to combine the teachings of the two references"
(App. Br. 5---6 (emphasis omitted); see Reply Br. 2-3 and 4).
Appellants' claim 1 is not directed to the "treatment or prevention of
erosive tooth demineralization," therefore, we are not persuaded by
Appellants' contentions relating to Appellants' intended use of the claimed
composition (App. Br. 6; see Reply Br. 3--4; cf Ans. 5 ("Appellant[s] [are]
arguing intended use")). "[T]he patentability of ... composition claims
depends on the claimed structure, not on the use or purpose of that
structure." Catalina Mktg. Int 'l, Inc. v. Coolsavings.com, Inc., 289 F.3d
801, 809 (Fed. Cir. 2002).
Further, Muhlemann exemplifies a composition comprising: 89.555%
water; 10.0% Glycerol, a C3 sugar alcohol; and 0.2% of an ammonium
cation of Appellants' formula (I) (FF 8) and Fiscella discloses the use of
di- and tri-carboxylic acids, at a concentration of between about 0.05% to
10% by weight of the composition, to stabilize the stannous ion in
compositions such as those disclosed by Muhlemann (FF 10-12). Thus,
notwithstanding Appellants' contention to the contrary, the combination of
Muhlemann and Fiscella suggest a composition comprising the "the very
specific ingredients, at [the] particular amounts, that are recited in
[Appellants'] claim 1" (App. Br. 6; see also FF 1-12). Absent evidence to
the contrary, the composition suggested by the combination ofMuhlemann
and Fiscella will contain the specific parts per million of fluoride ions and
tin, as well as the mol % of dissolved tin in the formal oxidation state +II,
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Application 12/989,578
required by Appellants' claim 1 (see Ans. 2-3). Therefore, we are not
persuaded by Appellants' contention that a person of ordinary skill in this art
would not have found it prima facie obvious to combine "the very specific
ingredients, at [the] particular amounts, that are recited in [Appellants']
claim 1," based on the combination ofMuhlemann and Fiscella (App. Br. 6).
Appellants contend that they disclose exemplary evidence (Example
19) comparing a composition within the scope of their claimed invention
(Example 7) to Meridol®, a commercial mouthrinse, and that this evidence
supports a finding that "the composition of Example 7 has an efficacy in
preventing demineralization, which is about 2 .2 times the efficacy of the
commercial Meridol® mouthrinse, which contain stannous fluoride in lieu of
tin from stannous chloride, as recited in [Appellants'] claim 1" (App. Br. 7;
see also Reply Br. 3 and 4---6). In this regard, Appellants' direct attention to
their Examples 21-26 to support a conclusion "that the increase in efficacy
of the formulations in Example 19 can possibly be attributed to the
combination of stannous chloride, [amine fluoride (AmF)], and organic acid,
and not simply to the increase of fluoride" in the compositions (App. Br. 7;
see also Reply Br. 4---6). We are not persuaded.
"[W]hen unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art." In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). On
this record, Appellants compared a composition falling within the scope of
their claimed invention with the commercially available mouthrinse,
Meridol® (see Ap. Br. 7 (citing Spec. Examples 7 and 19)). As Examiner
explains, Appellants do not identify "the components in the Meridol® mouth
rinse" (Ans. 6). At best, Appellants' Specification discloses that Meridol®
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Application 12/989,578
comprises "the amine hydrofluoride OLAFLUR in an amount corresponding
to 125 ppm fluoride and stannous fluoride in an amount also corresponding
to 125 ppm fluoride" (Spec. 2: 24--29; see also id. at 3: 13-17). Any
additional ingredients, or the concentration of additional ingredients in
Meridol® are not disclosed by Appellants. Therefore, it is not possible, on
this record, to determine whether Appellants' evidence of unexpected results
is made against: (a) the closest prior art of record or (b) some other
composition, i.e. commercially available composition. Accordingly, we are
not persuaded by Appellants' evidence of unexpected results.
Appellants' contentions relating to a reasonable expectation of success
are based on Appellants' evidence of unexpected results (see App. Br. 7-8).
Therefore, because we are not persuaded by Appellants' evidence of
unexpected results, we are equally unpersuaded by Appellants' contentions
regarding a reasonable expectation of success. In contrast, we find that the
evidence presented by Examiner provides a reasonable expectation of
success in using a composition suggested by the combination of Muhlemann
and Fiscella as a mouth rinse (see FF 1-12).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 1 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Muhlemann and Fiscella is
affirmed. Claims 2, 4--8, 10-12, 19-25, 27, and 28 are not separately argued
and fall with claim 1.
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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